Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma

NCT ID: NCT03343665

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-12-20

Brief Summary

A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory Hodgkins lymphoma.

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nivolumab 40 mg

Experimental: Nivolumab Nivolumab 40 mg IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Nivolumab 40 mg in 4 ml Injection

Intervention Type: DRUG

40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days

Interventions

Nivolumab 40 mg in 4 ml Injection

40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days

Intervention Type: DRUG

Other Intervention Names

Opdivo

Eligibility Criteria

Inclusion Criteria

• Diagnosis: Histologically confirmed Hodgkins lymphoma
• Relapsed or refractory disease after at least two prior lines of treatment
• Age 18-70 years old
• Signed informed consent
• No severe concurrent illness

Exclusion Criteria

• Uncontrolled bacterial or fungal infection at the time of enrollment
• Requirement for vasopressor support at the time of enrollment
• Karnofsky index <30%
• Pregnancy
• Somatic or psychiatric disorder making the patient unable to sign informed consent
• Active or prior documented autoimmune disease requiring systemic treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ivan S Moiseev

Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boris V Afanasyev, Ph.D

Role: PRINCIPAL_INVESTIGATOR

St. Petersburg State Pavlov Medical University

Locations

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, , Russia

Countries

Russia

References

Lepik KV, Fedorova LV, Kondakova EV, Zalyalov YR, Babenko EV, Lepik EE, Kotselyabina PV, Beynarovich AV, Popova MO, Volkov NP, Stelmakh LV, Baykov VV, Moiseev IS, Mikhailova NB, Kulagin AD, Afanasyev BV. A Phase 2 Study of Nivolumab Using a Fixed Dose of 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkin Lymphoma. Hemasphere. 2020 Sep 23;4(5):e480. doi: 10.1097/HS9.0000000000000480. eCollection 2020 Oct.

Reference Type: DERIVED

PMID: 33062947 (View on PubMed)

Other Identifiers

№30/17-н

Identifier Type: -

Identifier Source: org_study_id